Medication Monitor



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  • October 22, 2013

    Specialty Medicine Compounding Pharmacy announced a voluntary recall of all lots of certain unexpired human and veterinary sterile products to the consumer level due to particulate matter found in vials of a compounded dextrose injection product dispensed to a hospital within Michigan. Further testing and analysis of the medication is being conducted.

    The recalled products were distributed to hospitals and consumers located only within Michigan from July 1, 2013, through October 19, 2013. No products were distributed out of state.

    Patients should stop using the recalled product and contact the pharmacy at 248-446-2643, Monday through Friday, between 8:00 a.m. and 5:00 p.m. EDT to arrange for its return. Patients should contact their physician or health care provider if they have experienced any problems that may be related to using these products.

  • October 1, 2013

    FDA has added a boxed warning to the labeling of this I.V. drug product cautioning health professionals of increased risks of death when tigecycline is used for FDA-approved
    as well as for off-label uses to treat such conditions as diabetic foot infection or hospital-acquired or ventilator-associated pneumonia.

    Tigecycline is approved for treatment of complicated skin and skin structure infections (cSSSI), complicated intra-abdominal infections (cIAI), and community-acquired bacterial pneumonia (CABP).

    The current warning follows a 2010 FDA alert about a higher mortality risk when tigecycline was compared with other antibacterial drugs for treatment of cSSSI, cIAI, and CABP. In 10 clinical trials, deaths in tigecycline-treated patients most often resulted from worsening infections, complications of infection, or other underlying medical conditions, FDA said.
     

  • September 10, 2013

    Avella Specialty Pharmacy announced a voluntary recall of two compounded sterile medications, bevacizumab 1.25 mg/0.05 mL PF, lot #12-20130508@179; and vancomycin PF (BSS) 1%, lot #12-20130508@181. The recall is a result of concerns about sterility assurance with the pharmacy’s independent testing laboratory, Front Range Laboratories. To date, Avella has not received any reports of adverse events related to the recall.

    The recalled products were dispensed directly to health care providers nationwide, and the medications can be identified based on product label and corresponding medication name and lot number.

    Patients should contact their physician or health fcare provider if they have experienced any problems that may be related to taking or using this drug product. Patients and health care providers with questions about this recall can contact Avella at 877-738-0797 Monday through Friday between 6:00 am and 6:00 pm PST, or via e-mail at QA@avella.com.

  • July 30, 2013

    FDA has warned that consumers should not use or purchase Healthy Life Chemistry By Purity First B-50, marketed as a vitamin B dietary supplement. A preliminary FDA laboratory analysis indicated that the product contains two potentially harmful anabolic steroids: methasterone, a controlled substance, and dimethazine. These ingredients are not listed in the label and should not be in a dietary supplement.

    FDA has received reports of 29 adverse incidents associated with the use of the supplement. These reports include fatigue, muscle cramping, and myalgia (muscle pain), as well as abnormal laboratory findings for liver and thyroid function and cholesterol levels.

    Females who used this product reported unusual hair growth and missed menstruation, and males who used the product reported impotence and findings of low testosterone. Individuals who have used the product and have had any of these symptoms should consult a health professional and report their experience to FDA.

    Using anabolic steroid-containing products may cause acute liver injury. Some of the cases reported have resulted in hospitalization, but there were no reports of death or acute liver failure.

    In addition, anabolic steroids may cause other serious long-term consequences in women, men, and children. These include adverse effects on blood lipid levels, increased risk of heart attack and stroke, masculinization of women, shrinkage of the testicles, breast enlargement, infertility in males, and short stature in children.

    Healthy Life Chemistry By Purity First B-50 is manufactured by Mira Health Products Ltd. in Farmingdale, NY, and is sold on various websites and in retail stores. The company, Purity First Health Products, has declined to voluntarily recall the product or to warn consumers about the potential for injury.

    Health professionals are advised to ask their patients about any dietary supplements they may be using, particularly in patients exhibiting warning signs that may be associated with the use of steroids or steroid-like substances. These warning signs include liver injury, kidney failure and stroke. They also include hormone-associated adverse effects such as blood clots, including pulmonary embolism and deep vein thrombosis (a blood clot that forms in a vein deep in the body, often in the lower leg or thigh).

  • June 4, 2013

    FDA has announced that Nephron Pharmaceuticals Corporation is recalling the EZ Breathe Atomizer due to a manufacturing defect that could result in the washer ("Plate A") becoming dislodged. If this occurs, users may accidentally swallow the washer or choke on it.

    Devices were distributed between August 2012 and April 2013.

    The device was manufactured by Health & Life Co., LTD, and sold to Nephron Pharmaceuticals Corporation. Nephron Pharmaceuticals Corporation distributes the EZ Breathe Atomizer for sale and use in the Asthmanefrin Starter Kit. The EZ Breathe Atomizer was also sold by Nephron Pharmaceuticals Corporation as an individual device in a carton labeled EZ Breathe Atomizer, Model #EZ-100.

    Patients should stop using any EZ Breathe Atomizer units contained in the Asthmanefrin Starter Kits with the affected lot numbers and also those that were sold individually.

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